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NCT00637481 · ClinicalTrials.gov registry record · Phase 1

A Phase I Prevention Study of Atorvastatin in Women at Increased Risk for Breast Cancer

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
66
Enrollment target

NCT00637481: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT00637481 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 66 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00637481, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
66 participants
Enrollment target

Study Summary

Chemoprevention is the use of certain drugs to keep cancer from forming. The use of atorvastatin (Lipitor) may prevent breast cancer. This randomized phase I trial is studying the best dose of atorvastatin in preventing breast cancer in women at increased risk for breast cancer.

Primary Outcome

A single proliferation rate at each time period is calculated for each participant based on the proportion cells expressing KI-67.

Interventions

  • OTHER laboratory biomarker analysis
  • DRUG atorvastatin calcium

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2008-03
Est. Completion 2012-10
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00637481 record still lists

NCT00637481 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher).

The record links to 0 conditions, and to 2 interventions - of which laboratory biomarker analysis is the first listed.

NCT00637481 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00637481 about?

NCT00637481 is a clinical study titled "A Phase I Prevention Study of Atorvastatin in Women at Increased Risk for Breast Cancer". Chemoprevention is the use of certain drugs to keep cancer from forming. The use of atorvastatin (Lipitor) may prevent breast cancer. This randomized phase I trial is studying the best dose of atorvastatin in preventing breast cancer in women at increased risk for breast cancer.

What is the current status of trial NCT00637481?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2008-03. Estimated completion is 2012-10.

What interventions are being tested in trial NCT00637481?

The interventions under investigation include: laboratory biomarker analysis (OTHER), atorvastatin calcium (DRUG).

Who is sponsoring clinical trial NCT00637481?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00637481's enrollment target sits among peer trials

66 786th of 2000 higher than 1,203 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00637481, the US trial registry maintained by the National Library of Medicine. NCT00637481 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.